Leverage the Pain Toolbox to Enhance Clinical Trials
Maximizing clinical data & trial efficacy
There are countless pitfalls where a clinical trial could go awry and prove to be costly. Analgesic Solutions has developed a suite of tools for identifying reporting inconsistencies, screening potential subjects and reduce inaccuracies in data being collected. Implementing any of these tools at the start of your trial, complemented by our training programs, has proven to minimize trial oversights and increases the likelihood of trial efficacy. If your trial is underway and experiencing problems, Analgesic Solution’s tools can quickly identify the issues and get you back on track.
Bedside Sensory Testing Kit (BSTK)
Phenotype pain patterns
Pain studies fail for many reasons, one of which is that subjects with the same chronic pain condition can exhibit different symptoms which may be due to differences in underlying pain mechanisms. The BSTK can be used to collect patient’s sensory profile data which would allow for post-hoc phenotyping of patients that may provide insights into the underlying pain mechanisms responsive to active treatment versus placebo. This training program integrates seamlessly into the design of your clinical trial. Analgesic Solutions provides the BSTK components, case report form for easy integration into your EDC, and an instruction manual for site staff.
Find good pain reporters
The Focused Analgesia Selection Test is a psychophysical assessment which uses an FDA approved device to evaluate how accurately each subject reports pain by exposing subjects to painful thermal stimuli and recording their pain reports. These pain reports are entered into Analgesic Solutions’ proprietary algorithm that calculates the subjects FAST score, which may be used as an inclusion/exclusion criterion. Previous studies of the FAST assessment have shown that patients who demonstrate poor pain reporting capabilities on this test also perform poorly at reporting their pain during clinical trials. Therefore, inclusion of good pain reporters in your clinical trial increases assay sensitivity. The net result points to better clinical trial outcomes when pain is more accurately reported as a function of any given intervention. This may point to trial designs that require fewer subjects to demonstrate statistically significant results. In addition, new data emerging from ongoing work at Analgesic Solutions demonstrates the utility of FAST-T as a training tool to teach subjects to be better at reporting their pain. Due to the intimate overlap between pain reporting and this psychophysical assessment, sponsors opt to implement the Accurate Pain Reporting training program prior to the FAST. This serves to ensure that the subjects you exclude are those that truly do not grasp the concepts of accurately reporting pain which leads to a good subject population, improved data quality and a potential positive outcome for your clinical trial.
Staircase Procedure (STEPP)
Measure evoked pain in OA
Standard evoked pain procedures have been shown over many decades of pain research to more accurately assess the effect of analgesic treatments than naturalistic approaches, such as self-reported averages over time, rest pain, etc. Analgesic Solutions has developed one model, Staircase Procedure, as a performance-based procedure to evoke pain in patients with osteoarthritis (OA) of the hip or knee to demonstrate the impact of active treatment versus placebo on physical function. The benefit of our evoked pain model is that it assesses aspects of pain that are more relevant to the functional limitations imposed on patients by their OA pain, may be repeated multiple times on the same day allowing for evaluation of efficacy over a relatively short period-of-time (time course of analgesia), complements patient self-report measures of physical function, and is safe and well-tolerated. Analgesic Solutions provides the staircase, and a case report form for easy integration into your EDC. The Analgesic Solutions Staircase Procedure training program integrates seamlessly into the design of your clinical trial, requires only nominal up front time commitment, and yields long standing positive outcomes.
Masquerading Disorders Tool (MDT)
Screen for disorders that mimic painful diabetic neuropathy
Failed clinical trials (i.e., drug works but the trial fails to show it) are common in painful diabetic neuropathy (PDN). One potential cause of failed PDN studies is inadvertent enrollment of subjects whose foot pain is not due to PDN. Analgesic Solutions has developed a screening instrument, Masquerading Disorders Tool (MDT), to efficiently and systematically identify subjects with disorders that masquerade as PDN. The exclusion of subjects without the target disorder improves assay sensitivity within your PDN clinical trial. Analgesic Solutions provides two easy to use forms, a screening form and an in-clinic examination form, to document the presence of disorders that can mimic PDN (e.g., plantar fasciitis, ischemic pain). The in-clinic foot examination is a key component of the screening process and should be conducted by a qualified healthcare professional to make a diagnosis. The MDT training program integrates seamlessly into the design of your clinical trial, requires only nominal up front time commitment, and yields long standing positive outcomes.
OPIOID INDUCED HYPERALGESIA (OIH)
Quantify Opioid Induced Hyperalgesia
Opioid induced hyperalgesia (OIH) is a condition which is multi-faceted and ultimately presents in some subjects as increased pain while on long-term opioid therapy. The Quantitative Sensory Test is a psychophysical assessment which uses an FDA approved device to capture QST endpoints (such as phasic pain intensity, controlled pain modulation, tonic pain intensity, temporal summation) to test for the presence or absence of OIH. A review of the literature revealed that heat pain was the most promising stimulus modality for detecting OIH. As such, subjects are exposed to heat within the context of 6 QST modules within which a set number of pain scores are captured at various intervals unique to the module. Each QST module is thought to measure different pro- and anti-nociceptive mechanisms which may be altered due to the presence of OIH. Phasic pain intensity (PPI) and tonic pain intensity (PPI) test the pain sensitivity to oscillating and constant noxious heat stimuli, whereas temporal summation (TS) tests an increase of pain sensation to repetitive noxious stimuli. Conditioned pain modulation (CPM) can be used to test the extent of endogenous inhibitory pain mechanisms. Due to the intimate overlap between pain reporting and this psychophysical assessment, sponsors opt to implement the Accurate Pain Reporting training program prior to the QST. Implementation involves hands on site training by an Analgesic Solutions trainer.
CENTRAL ELIGIBILITY VERIFICATION (CEV)
Eligibility criteria for clinical trials are designed to ensure the safety of clinical research subjects and support the scientific objectives of a study. Accurate selection of clinical trial subjects is critical for demonstration of efficacy. Correct identification of the target clinical syndrome, and identification of disorders that may masquerade as the target syndrome, may be challenging for investigators, especially for more complex disorders such as painful diabetic neuropathy and post-traumatic peripheral neuropathy. However, even for seemingly common disorders, such as osteoarthritis of the knee, interpretation of standard diagnostic criteria is subject to great variability.
Central Eligibility Verification consists of developing an intake form for investigators to capture key information needed for accurate subject assessment, and having these forms reviewed in quasi-real time by independent experts to determine whether screened subjects can be enrolled into the trial. The independent experts are trained to interpret the standard diagnostic criteria in a consistent manner. By removing the decision-making process from investigators, Central Eligibility Verification serves to minimize subject selection bias, reduce enrollment error, minimize risks to subjects, and increases the likelihood of demonstrating trial efficacy with cost-effectiveness.